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Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate

NCT01150526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-07-18

No results posted yet for this study

Summary

The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or CaHMB treatment following a bout of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and IL-18); and (3) muscle strength recovery and soreness.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

CaHMB

CaHMB capsules with each capsule containing 0.8 g of HMB

DIETARY_SUPPLEMENT

HMB Free Acid Gel

HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid

DIETARY_SUPPLEMENT

Placebo

Placebo capsules similar in size and color to the CaHMB capsules used in the study

DIETARY_SUPPLEMENT

Placebo Gel Dosage

A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel

Sponsors & Collaborators

  • Iowa State University

    collaborator OTHER

  • Metabolic Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • John A Rathmacher, PhD · Metabolic Technologies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-11-30
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01150526 on ClinicalTrials.gov